It is increasingly recognized that several chronic diseases display rhythmic patterns in the manifestation of symptoms. In this field there is particular interest in those conditions for which symptoms are generally aggravated in the morning. These early morning pathologies are typically treated by either night-time administration of conventional medicines or relatively constant administration of therapeutic agents with the goal of maintaining constant levels of drug in the system of the afflicted subject. By this protocol, the therapeutic benefit of the drag is assured at the time of awakening when the symptoms are generally more pronounced. Unfortunately, the low compliance of patients or the continual exposure of the system to therapeutic agents may be undesirable in some subjects or some situations. In an ideal clinical situation, drug treatment would result in highest peak plasma concentrations around the time of most frequent occurrence of symptoms. In this instance the ideal drug delivery system should allow administration at bed-time and delay the release of the drug for as many hours as is required to reach therapeutic blood levels at the more appropriate time.
Accordingly, it is an object of the present invention to provide methods of treating early morning pathologies which provide therapeutic benefits to the subject suffering therefrom while avoiding unnecessary exposure of the body to the therapeutic agent. It is a further object of the present invention to provide a pharmaceutical formulation for the time-specific delivery of a pharmaceutically active agent for the treatment of early morning pathologies.